simvastatin

(sim va stah' tin)

Zocor

Pregnancy Category X

Drug classes
Antihyperlipidemic
HMG-CoA inhibitor

Therapeutic actions
Inhibits HMG-CoA, the enzyme that catalyzes the first step in the cholesterol synthesis
pathway, resulting in a decrease in serum cholesterol, serum LDLs, and either an increase
or no change in serum HDLs.

Indications
• Adjunct to diet in the treatment of elevated total cholestrol and LDL cholesterol
with primary hypercholesterolemia (types IIa and IIb) in those unresponsive to
dietary restriction of saturated fat and cholesterol and other nonpharmacologic
measures
• To reduce the risk of coronary disease, mortality, and CV events, including stroke,
TIA, MI and reduction in need for bypass surgery and angionplasty in patients
with coronary heart disease and hypercholesterolemia
• Treatment of patients with isolated hypertriglyceridemia
• Treatment of type III hyperlipoproteinemia

Contraindications and cautions

• Contraindicated with allergy to simvastatin, fungal byproducts, pregnancy,
lactation.
• Use cautiously with impaired hepatic and renal function, cataracts.

Available forms
Tablets—5, 10, 20, 40, 80 mg

Dosages
ADULTS
Initially, 20 mg PO up to 80 mg PO daily in the evening. Usual range, 5–80 mg/day.
Maximum dose, 80 mg/day. Adjust at 4-wk intervals.
• Familial hypercholesterolemia: 40 mg/day PO in the evening, or 80 mg/day
divided into doses of 20 mg, 20 mg, and 40 mg in the evening.
• Combination therapy: Do not combine with other statins; if used with fibrates or
niacin, do not exceed 10 mg/day; regular dose if combined with bile acid
sequestrants. Combined with cyclosporine, start with 5 mg/day; do not exceed
10 mg/day.
PEDIATRIC PATIENTS
Safety and efficacy not established.
GERIATRIC PATIENTS AND PATIENTS WITH RENAL IMPAIRMENT
Starting dose, 5 mg/day PO; increase dose slowly, monitoring response.

Pharmacokinetics
Route Onset Peak
Oral Slow 1.3–2.4 hr

Metabolism: Hepatic; T1/2: 3 hr

Distribution: Crosses placenta; enters breast milk
Excretion: Urine and feces

Adverse effects
• CNS: Headache, asthenia, sleep disturbances
• GI: Flatulence, diarrhea, abdominal pain, cramps, constipation, nausea,
dyspepsia, heartburn, liver failure
• Respiratory: Sinusitis, pharyngitis
• Other: Rhabdomyolysis, acute renal failure, arthralgia, myalgia

Interactions
Drug-drug
• Increased risk of myopathy and rhabdomyolysis with amiodarone, verapamil; do
not exceed 20 mg simvastatin daily
• Increased risk of myopathy and rhabdomyolysis with clarithromycin,
erythromycin, HIV protease inhibitors, itraconazole, ketoconazole, nefazodone;
avoid concomitant use, or suspend therapy during treatment with clarithromycin,
erythromycin, itraconazole, and ketoconazole
• Increased risk of myopathy and rhabdomyolysis with cyclosporine, fibrates,
niacin; monitor patient closely if use together can’t be avoided. Don’t exceed
10 mg simvastatin daily
• Digoxin levels may increase slightly; closely monitor plasma digoxin levels at the
start of simvastatin therapy
• Increased risk for hepatotoxicity with hepatotoxic drugs; avoid concurrent use
• Simvastatin may slightly enhance the anticoagulant effect of warfarin; monitor PT
and INR at the start of therapy and during dose adjustment
Drug-food
• Decreased metabolism and risk of toxic effects if combined with grapefruit juice;
avoid this combination

Nursing considerations
Assessment
• History: Allergy to simvastatin, fungal byproducts; impaired hepatic function;
pregnancy; lactation
• Physical: Orientation, affect; liver evaluation, abdominal exam; lipid studies,
liver function tests

Interventions
 • Ensure that patient has tried a cholesterol-lowering diet regimen for 3–6 mo
before beginning therapy.
• Give in the evening; highest rates of cholesterol synthesis are between midnight
and 5 AM.
• Advise patient that this drug cannot be taken during pregnancy; advise patient to
use barrier contraceptives.
• Arrange for regular follow-up during long-term therapy. Consider reducing dose
if cholesterol falls below target.

Teaching points
• Take drug in the evening. Do not drink grapefruit juice while using this drug.
• Have periodic blood tests.
• This drug cannot be taken during pregnancy; using barrier contraceptives is
recommended.
• These side effects may occur: Nausea (eat frequent small meals); headache,
muscle and joint aches and pains (may lessen); sensitivity to light (use a suncreen
and wear protective clothing).
• Report severe GI upset, changes in vision, unusual bleeding or bruising, dark
urine or light-colored stools, fever, muscle pain, or soreness.

Adverse effects in Italic are most common; those in Bold are life-threatening.